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Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) VieScope or b) videolaryngoscopy.
Tracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. In patients with an expected difficult airway, tracheal intubation is often performed by videolaryngoscopy (VL). However, this technique has limitations and may fail due to insufficient visualization of the larynx. A new device has been introduced that consists of an illuminated straight plastic tube for laryngoscopy (VSC, Vie Scope, Adroit Surgical, Oklahoma City, OK, USA) that enables for indirect intubation over a stylet.
So far, the VSC has shown promising results in manikin studies for intubation in normal and difficult airways. We aim to test the VSC in patients compared to videolaryngoscopy in a prospective randomized non-inferiority trial.
Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the University Medical Center Hamburg-Eppendorf prior to elective surgery. All patients receive a structured preoperative airway assessment.
Patients are randomized 1:1 to either intervention or control group. Patients randomized to the intervention group will be intubated with the VSC. Patients randomized to the control group are intubated with a MacIntosh type videolaryngoscope (CMAC, Storz, Germany).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VieScope | Experimental | intubation with the VieScope laryngoscope |
|
| Videolaryngoscopy | Active Comparator | intubation with videolaryngoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VieScope | Device | intubation with VieScope laryngoscope |
| |
| Videolaryngoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Glottis Opening (POGO) scale | intubating conditions according to the percentage of glottis opening scale (POGO), range 0-100%, higher values better | 15 min |
| Measure | Description | Time Frame |
|---|---|---|
| first attempt success rate | percentage of successful intubations with one attempt | 15 min |
| time to intubation | time until tracheal airway access is established |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joern Grensemann, MD | Universitätsklinikum Hamburg-Eppendorf | Study Chair |
| Martin Petzoldt, MD | Universitätsklinikum Hamburg-Eppendorf | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37537324 | Derived | Petzoldt M, Grun C, Wunsch VA, Bauer M, Hardel TT, Grensemann J. Vie Scope(R) versus videolaryngoscopy in expected difficult airways: a randomized controlled trial. Can J Anaesth. 2023 Sep;70(9):1486-1494. doi: 10.1007/s12630-023-02534-y. Epub 2023 Aug 3. |
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randomized 1:1
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device for intubation may not be blinded for provider or investigator
| Device |
intubation with videolaryngoscope |
|
| 15 min |
| Cormack-Lehane | intubating conditions according to Cormack-Lehane | 15 min |
| overall success rate | percentage of successful intubations with the allocated procedure | 15 min |
| time to successful intubation with one attempt | time until tracheal airway access is established in patients that are intubated at first attempt | 15 min |
| intubation difficulty | subjective rating on a visual analogue scale (0-100, higher values indicate more difficult intubation) of the difficulty of airway management and questionnaire | 15 min |
| number of attempts | total number of attempts until airway established | 15 min |
| aspiration | percentage of patients that vomit and aspirate during intubation | 15 min |
| esophageal intubation | percentage of accidental esophageal intubation attempts | 15 min |
| hypoxia | percentage of patients with a desaturation below a pulsoximetric saturation of 80% | 15 min |
| hypotension | percentage of patients with a systolic blood pressure below 70 mmHg | 15 min |